Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study - Full Text View

Sponsor:	University of Pennsylvania
Collaborator:	Forest Laboratories
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00523705

Purpose

The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.

Condition	Intervention
Premenstrual Syndrome	Drug: escitalopram Other: placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Menstruation Premenstrual Syndrome

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Subject daily symptom rating score. [ Time Frame: Throughout study (~5 months). ] [ Designated as safety issue: No ]
Clinician global impressions (CGI score). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sheehan Disability Scale (SDS) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Steiner Premenstrual Tension Scale (PMTS) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Patient Global Evaluation of Improvement (PGE) [ Time Frame: Throughout treatment ] [ Designated as safety issue: No ]
Subject Satisfaction Questionnaire [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.	Drug: escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
2: Placebo Comparator Placebo tablets matched to drug.	Other: placebo Placebo tablets matched to drug

Detailed Description:

The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.

Eligibility

Ages Eligible for Study:	15 Years to 19 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females 15-19 years of age
Regular menstrual cycles of 22-35 days
In general good health
Medically approved birth control method if sexually active
Evidence of ovulation
Meeting all symptom criteria for PMS
Signed informed consent
Subjects under age 18 must also have signed parental consent

Exclusion Criteria:

Current use of any treatment for PMS.
Psychotropic or other medications that may compromise the study drug.
Pregnancy, intending pregnancy or breast feeding.
Not using a medically approved birth control method if sexually active.
Significant medical or gynecological abnormalities.
Irregular menses, any gynecologic disorder.
Any severe or unstable medical illness.
Any current major psychiatric diagnosis or any history of a major psychiatric diagnosis.
Any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar disorder, psychosis or severe personality disorder.
Use of triptans (Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, Relpax).
Use of medicines that include dextromethorphan such as Tylenol or Vicks cough medicines.
Use of the pain medication meperidine.
Use of any herbal product such as St John's Wort that may increase serotonin.
Use of monoamine oxidase inhibitors (MAOIs), pimozide or citalopram hydrobromide.
Drugs metabolized by CYP2D6 or a combination of CYP3A4 and CYP2D6 inhibitors.
Hypersensitivity to escitalopram or citalopram.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523705

Contacts

Contact: Naseem Kerr, MPH	215-662-3329	nkerr@mail.med.upenn.edu
Contact: Cheryl Irving, BA	215-662-3329	cirving@mail.med.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania, Dept Ob/Gyn, 3701 Market St, Suite 820 (Mudd)	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Cheryl Irving, AB 215-662-3329 cirving@mail.med.upenn.edu
Principal Investigator: Ellen W Freeman, PhD

Sponsors and Collaborators

University of Pennsylvania

Forest Laboratories

Investigators

Principal Investigator:

Ellen Freeman

University of Pennsylvania

More Information

Publications:

Vichnin M, Freeman EW, Lin H, Hillman J, Bui S. Premenstrual syndrome (PMS) in adolescents: severity and impairment. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):397-402.

Responsible Party:	University of Pennsylvania, Department of Obstetrics/Gynecology ( Ellen W. Freeman, PhD, Research Professor )
Study ID Numbers:	805778, LXP-MD-123 (Forest Pharm)
Study First Received:	August 30, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00523705 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:

premenstrual syndrome
PMS
PMDD
treatment
SSRI

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Menstruation Disturbances
Therapeutic Uses
Syndrome

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Premenstrual Syndrome

ClinicalTrials.gov processed this record on November 30, 2009